title: Treatment of acute schizophrenia with paliperidone ER: predictors for treatment response and benzodiazepine use.
abstract: The Paliperidone ER Treatment in Acute Intervention (PERTAIN) study was designed to explore treatment response, tolerability, and safety of flexible doses of paliperidone ER in patients with schizophrenia admitted for an acute exacerbation. This paper addresses a secondary analysis of PERTAIN data designed to explore predictors for treatment response, flexible dosing, and concomitant benzodiazepine use. This prospective, multicenter, phase 3b, open-label, single-arm, 6-week study used flexible doses of paliperidone ER (3 to 12mg once daily) to treat patients hospitalized for an acute exacerbation of schizophrenia, reflecting more closely daily clinical practice. Predictive models were evaluated for paliperidone ER flexible dosing, treatment response, and concomitant treatment with benzodiazepines as distinct independent variables. For the analysis of explanatory variables, a stepwise logistic regression was used, taking into account patient age, gender, body mass index, diagnosis and duration of schizophrenia, number of prior hospitalizations, psychotic symptoms (PANSS), disease severity (CGI-S), and patient functioning (PSP) at baseline. Early response (defined as response within 2weeks of treatment initiation) was also used as a predictor. Clinical response (defined as ≥30% decrease in PANSS total score and ≥1 point decrease in CGI-S from baseline to endpoint) was predicted by early clinical response (p<0.001) and there was a trend for the diagnosis of paranoid schizophrenia vs. other types of schizophrenia to predict clinical response (p=0.0525). High response (defined as ≥50% decrease in PANSS total score and ≥2 points decrease in CGI-S from baseline to endpoint) was predicted by early high response, higher baseline CGI-S, or female gender. More severely ill patients with a higher baseline CGI-S were twice likely to be treated concomitantly with a benzodiazepine.
authors.affiliation: Klinik und Poliklinik für Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar, Moehlstrasse 26, 81675, Munich, Germany. Electronic address: s.heres@lrz.tu-muenchen.de.
authors.forename: Stephan
authors.initials: S
authors.lastname: Heres
authors.forename: Liana
authors.initials: L
authors.lastname: Don
authors.forename: Miroslav
authors.initials: M
authors.lastname: Herceg
authors.forename: Leszek
authors.initials: L
authors.lastname: Bidzan
authors.forename: Michel
authors.initials: M
authors.lastname: Blanc
authors.forename: Alberto
authors.initials: A
authors.lastname: Siracusano
authors.forename: Valentinas
authors.initials: V
authors.lastname: Maciulis
authors.forename: Marjolein
authors.initials: M
authors.lastname: Lahaye
authors.forename: Andreas
authors.initials: A
authors.lastname: Schreiner
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011743:Pyrimidines / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D007555:Isoxazoles; D011743:Pyrimidines; D001569:Benzodiazepines; D000068882:Paliperidone Palmitate
keywords: Acute schizophrenia; BMI; Benzodiazepine use; CGI-S; CI; Clinical Global Impression—Severity; Clinical predictors; DSM-IV; Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; ER; OR; PANSS; PERTAIN; PSP; Paliperidone ER; Paliperidone ER Treatment in Acute Intervention; Personal and Social Performance; Positive and Negative Syndrome Scale; SD; Treatment response; body mass index; confidence interval; extended release; odds ratio; standard deviation